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Duramorph Pf (Morphine Sulfate)
Duramorph Pf works by binding to opioid receptors in the brain and spinal cord, mimicking the natural pain-relieving chemicals in the body.
Duramorph Pf (Morphine Sulfate) is a small molecule opioid agonist that targets the mu-type opioid receptor. It is used to treat various pain conditions, including acute postoperative pain, chronic pain with opioid tolerance, and labor pain. Originally developed by Pfizer Inc., it is now owned by Allergan. Duramorph Pf is available as a generic medication, with 32 generic manufacturers, and is off-patent. It has a half-life of 2.0 hours and bioavailability of 24%.
At a glance
| Generic name | Morphine Sulfate |
|---|---|
| Sponsor | Pfizer |
| Drug class | Opioid Agonist |
| Target | Mu-type opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Mechanism of action
Mechanism of Action. Morphine is full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play role in the analgesic effects of this drug.
Approved indications
- Acute postoperative pain
- Chronic Pain with Opioid Tolerance
- Chronic pain
- Diarrhea
- General anesthesia
- Local anesthesia
- Pain
- Regional Anesthesia for Labor Pain
- Regional Anesthesia for Surgery
- Severe pain
Boxed warnings
- WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS Addiction, Abuse, and Misuse Because the use of morphine sulfate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1 )]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of morphine sulfate tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate tablets are essential [see Warnings and Precautions ( 5.2 )]. Accidental Ingestion Accidental ingestion of even one dose of morphine sulfate tablets, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions ( 5.2 )] . Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of morphine sulfate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7 )]. Neonatal Opioid Withdrawal Syndrome (NOWS) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions ( 5.4 )]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions ( 5.5 )]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MORPHINE SULFATE TABLETS See full prescribing information for complete boxed warning. Morphine sulfate tablets expose users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and regularly evaluate for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of morphine sulfate tablets are essential. ( 5.2 ) Accidental ingestion of morphine sulfate tablets, especially by children, can result in a fatal overdose of morphine. ( 5.2 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. ( 5.5 )
Common side effects
- Respiratory depression
- Respiratory arrest
- Cardiac arrest
- Shock
- Circulatory depression
- Apnea
- Constipation
- Nausea
- Somnolence
- Lightheadedness
- Dizziness
- Sedation
Drug interactions
- butorphanol
- nalbuphine
- naltrexone
- rasagiline
- rifampicin
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine (PHASE3)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion (EARLY_PHASE1)
- Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
- Analgesic Effects of Intrathecal Morphine and Transversalis Plane Block After Cesarean Delivery
- Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9192608 | 2034-03-12 | Method of Use |
| 9549899 | 2033-07-01 | Formulation |
| 9044402 | 2033-07-01 | Formulation |
| 9248229 | 2034-03-12 | Formulation |
| 7955619 | 2028-08-12 | Formulation |
| 9072781 | 2034-03-12 | Formulation |
| 10314788 | 2028-08-12 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Duramorph Pf CI brief — competitive landscape report
- Duramorph Pf updates RSS · CI watch RSS
- Pfizer portfolio CI